Cleared Traditional

K162804 - Q2 Low Pressure Power Injection Extension Set

K162804 is an FDA 510(k) clearance for Q2 Low Pressure Power Injection Extensi..., manufactured by Quest Medical, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K162804 · Quest Medical, Inc. · General Hospital
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Mar 2017
Decision
154d
Days
Class 2
Risk

K162804 is an FDA 510(k) clearance for the Q2 Low Pressure Power Injection Extension Set. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Quest Medical, Inc. (Allen, US). The FDA issued a Cleared decision on March 8, 2017 after a review of 154 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Quest Medical, Inc. devices

FDA 510(k) Submission Details - K162804

510(k) Number K162804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2016
Decision Date March 08, 2017
Days to Decision 154 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 129d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FPA Set, Administration, Intravascular

All 770
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K162804.
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K162601 · Shinva Ande Healthcare Apparatus Co., Ltd. · May 2017
Sterile Single-use Infusion Set
K163160 · Jiangxi Hongda Medical Equipment Group , Ltd. · Apr 2017
Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set
K161898 · Beijing Fert Technology Co., Ltd. · Mar 2017
Hospira Extension Set, Hospira Primary Set
K161036 · Hospira, Inc. · Jan 2017
Paclitaxel Sets
K160007 · Baxter Healthcare Corporation · Dec 2016
Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets
K162304 · Quest Medical, Inc. · Dec 2016